The Pharma Marketing Glossary

When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's requirements for marketing approval, the sponsor submits to FDA a new drug application (NDA). The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics. If the NDA is approved, the product may be marketed in the United States. For internal tracking purposes, all NDA's are assigned an NDA number.

Source: Food and Drug Administration

New Molecular Entity (NME)

A New Molecular Entity (NME) or New Chemical Entity (NCE) is a drug or chemical that is without precedent among regulated and approved drug products. The NME designation indicates that a drug in development is not a version or derivative of an existing and previously investigated, trialed and approved substance. Being labeled as entirely 'new' or first-in-class molecule dictates that certain types of clinical trials must be run, and that particular attention must be paid to proving a drugs safety.

New Prescriptions (NRx)

Precise measurement of pharma marketing's impact requires physician presciption (Rx) data. One metric used is the number of new prescriptions (NRx; TNew Prescriptions) written by physicians for a particular drug over a specific period of time. NRx does NOT include prescriptions for refills, but does include renewals, which are scripts patients get when they run out of refills. In contrast, TRx (Total Prescriptions) includes refills AND renewals.

Pharmaceutical companies purchase physician-level prescribing data from companies such as IMS. These data guide pharma salesforce strategies. For example, drug companies can save money by distributing free samples of a new drug only to the biggest prescribers of products in that same class. Sales reps can also use the data to verify their physician clients have prescribed the drugs as promised during sales calls. That information would change the sales messaging in followup calls.

Traditionally, the total prescriptions (TRx) metric has been a key metric used by the pharmaceutical industry to gauge a medicine's launch performance. However, this metric lags compared to the new-to-brand (NBRx) metric, resulting in delayed decisions and non-optimal brand performance. IMS research has found that NBRx is a more valuable metric in differentiating between a true new patient -- one who has never been on the brand before -- and a new prescription (NRx), which in many cases is actually for a patient continuing on therapy.

Non-personal promotion (NPP) usually means promotion via electronic means, e.g., via email/Internet, rather than via person-to-person, e.g., sales rep to physician, contact. eDetailing is a form of NPP. One benefits of NPP messaging is that physicians can access information at a time of their choosing. NPP does not mean "impersonal." The most successful NPP involves personalization of the message so that it is appropriate for the intended audience or segment of an audience. Email messages, for example, can include the name of the recipient and be tailored to the needs of the recipient.

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The Pharma Marketing Network® was established in 2003 by John Mack (aka Pharmaguy). Our ongoing mission is to continue the work John started; speaking truth to power, asking tough questions, and building this ever-growing community of conscientious professionals.